HomeNDC LookupIngredientsFlecainide Acetate › 53746-0643-01
Flecainide Acetate 150 mg Tablet, 100-count — NDC 53746-0643-01 package photo

Flecainide Acetate 150 mg Tablet, 100-count

by Amneal Pharmaceuticals of New York LLC · 100 TABLET in 1 BOTTLE (53746-643-01)
NDC 53746-0643-01
🏷️ FDA NDC (as labeled) 53746-643-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.2590 NADAC Per package$25.90 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4552/unit · Part D plans $0.2193/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 53746-643-01
Product NDC 53746-643
11-digit billing NDC 53746064301
NCPDP billing unit EA — each (per item)
RxCUI 886662, 886666, 886671
UNII M8U465Q1WQ
UPC 0353746643018
Application # ANDA075442
SPL Set ID ee9595d5-08a1-4529-9215-ddc3c7f929c4
Established class (EPC) Antiarrhythmic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-12-01
Route ORAL
Dosage form TABLET
Substance FLECAINIDE ACETATE
GCN Seq No 000264
GCN 01582
HICL code 000082
Ingredient (HICL) Flecainide Acetate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A2
Therapeutic class — intermediate (HIC2) Cardiac Depressants
HIC3 code A2A
Therapeutic class — specific (HIC3) Antiarrhythmics
AHFS code 24:04.04.12
AHFS class Class Ic Antiarrhythmics
FDB label name FLECAINIDE ACETATE 150 MG TAB
FDB brand name Flecainide Acetate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 53746-643-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53746-0643-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic
Drug family (ATC) Antiarrhythmics, class Ic
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAmneal Pharmaceuticals of New York LLC
Application holderAMNEAL PHARMACEUTICAL
FDA applicationANDA075442 (ANDA)
Labeler code53746
First marketedDec 2009
Product typeHuman Prescription Drug
Portfolio228 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FLECAINIDE ACETATE 150 MG TAB Ingredient Flecainide Acetate
📖 What it is MedlinePlus · NLM

Flecainide is used to prevent certain types of life-threatening irregular heartbeats. Flecainide is in a class of medications called antiarrhythmics. It works by slowing electrical signals in the heart to stabilize the heart rhythm.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Flecainide slows down the electrical signals in your heart — think of it as turning down the speed on chaotic or too-fast electrical firing. This helps your heart stay in a normal,...
  • What is flecainide actually doing for my heart?
  • Yes, and this is the most important thing to know about this medication. Like other antiarrhythmics, flecainide can sometimes trigger new or more dangerous heart rhythms — this is...
  • Can flecainide actually make my heart rhythm worse?
📖 Read our full Flecainide guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeOval
ImprintAN;643
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.259 $25.90 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.4552 $45.52 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2193 $21.93 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.469 $0.254
▼ Down 35% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Flecainide Acetate 150 mg 42806-0819-01 Epic 100 tablets $0.259 AB Availability likely
Flecainide Acetate 150 mgthis 53746-0643-01 Amneal 100 tablets $0.259 AB Availability likely
Flecainide Acetate 150 mg 57237-0065-01 Rising 100 tablets $0.259 AB Availability likely
Flecainide Acetate 150 mg 62135-0662-60 Chartwell 60 tablets $0.259 Availability likely
Flecainide Acetate 150 mg 62559-0382-01 ANI 100 tablets $0.259 AB Availability likely
Flecainide Acetate 150 mg 65862-0623-01 Aurobindo 100 tablets $0.259 Availability likely
Flecainide Acetate 150 mg 76385-0147-01 UNICHEM 100 tablets $0.259 AB Availability likely
Flecainide Acetate 150 mg 65162-0643-10 Amneal 100 tablets $0.324 AB FDA listed +25%
Flecainide Acetate 150 mg 00054-0012-20 Hikma 100 tablets AB FDA listed
Flecainide Acetate 150 mg 51407-0020-01 Golden 100 tablets AB FDA listed
Flecainide Acetate 150 mg 63629-1981-01 Bryant 100 tablets AB FDA listed
Flecainide Acetate 150 mg 71335-2172-01 Bryant 30 tablets AB FDA listed
Flecainide Acetate 150 mg 71335-2523-01 Bryant 30 tablets AB FDA listed
Flecainide Acetate 150 mg 71335-2655-01 Bryant 30 tablets AB FDA listed
Flecainide Acetate 150 mg 72162-1762-01 Bryant 100 tablets AB FDA listed
Flecainide Acetate 150 mg 72789-0384-01 PD-Rx 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 53746-0643-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.7K
Units reimbursed last 4 qtrs
112.7K
Gross reimbursed last 4 qtrs
$51.3K
Avg / prescription
$29.93
Avg / unit
$0.4552
Latest quarter Q4 2025
425Rx
Medicaid pays / ea
$0.4552
gross reimbursed
vs
NADAC / ea
$0.2590
acquisition cost
=
Spread
+$0.1962
+76% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
33% FFS 67% MCO
Fee-for-service · 565 Rx Managed care · 1,149 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,499 units · 44.8 per 100k residents WA Idaho: 423 units · 21.5 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,838 units · 48.0 per 100k residents WI Michigan: 4,610 units · 45.9 per 100k residents MI New York: 7,270 units · 37.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 8,184 units · 193 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,582 units · 20.6 per 100k residents IL Indiana: no data reported IN Ohio: 5,264 units · 44.7 per 100k residents OH Pennsylvania: 8,310 units · 64.1 per 100k residents PA New Jersey: 4,492 units · 48.4 per 100k residents NJ Massachusetts: no data reported MA California: 11,410 units · 29.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 8,372 units · 135 per 100k residents MO Kentucky: 5,130 units · 113 per 100k residents KY West Virginia: 3,043 units · 172 per 100k residents WV Virginia: 5,006 units · 57.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 5,922 units · 79.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 630 units · 20.5 per 100k residents AR Tennessee: 1,725 units · 24.2 per 100k residents TN North Carolina: 7,532 units · 69.5 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 1,252 units · 30.9 per 100k residents OK Louisiana: 3,928 units · 85.9 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 390 units · 1.7 per 100k residents FL
Units reimbursed · per 100k residents
1.7193
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oregon 193 /100k
2 West Virginia 172 /100k
3 Missouri 135 /100k
4 Kentucky 113 /100k
5 Louisiana 85.9 /100k
6 Arizona 79.7 /100k
7 North Carolina 69.5 /100k
8 Pennsylvania 64.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets53746-0643-10 No Medicaid data
Drug total (last 4 qtrs): 1,714 Rx · 112,682 units · $51,292 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Flecainide Acetate — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Flecainide Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.61M
Claims incl. refills
336.2K
Beneficiaries
260.6K
Spend / beneficiary
$44.56
Spend / claim
$34.54
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Flecainide acetate — the ingredient across all brands.

Top reported reactions

Atrial Fibrillation350
Fatigue287
Dyspnoea283
Dizziness271
Nausea251
Headache224
Diarrhoea216

Age at onset

Neonate15
Infant12
Child5
Adolescent4
Adult243
Elderly498

Reporter sex

5,246 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization2,102
Death444
Life-threatening300
Disabling132
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 322 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
53746-0643-01 You're viewing this 100 TABLET in 1 BOTTLE (53746-643-01) $0.2590 / ea $25.90 2009-12-01 Active
53746-0643-10 1000 TABLET in 1 BOTTLE (53746-643-10) 2009-12-01 Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 53746-0643-01?
NDC 53746-0643-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 53746-0643-01 and NDC 53746-0643-10?
Both are Flecainide Acetate 150 mg Tablet — the drug itself is identical. NDC 53746-0643-01 is the 100-count package, while NDC 53746-0643-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Flecainide Acetate 150 mg Tablet?
Bill NDC 53746-0643-01 — the 11-digit billing format is 53746064301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 209 words

INDICATIONS AND USAGE In patients without structural heart disease, flecainide is indicated for the prevention of - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Flecainide is also indicated for the prevention of - documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician, are life-threatening.

Use of flecainide for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.

Flecainide should not be used in patients with recent myocardial infarction (see Boxed WARNINGS ). Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended (see Boxed WARNINGS ). As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide favorably affects survival or the incidence of sudden death.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION For patients with sustained VT, no matter what their cardiac status, flecainide, like other antiarrhythmics, should be initiated in hospital with rhythm monitoring. Flecainide has a long half-life (12 to 27 hours in patients). Steady-state plasma levels, in patients with normal renal and hepatic function, may not be achieved until the patient has received 3 to 5 days of therapy at a given dose.

Therefore, increases in dosage should be made no more frequently than once every four days , since during the first 2 to 3 days of therapy the optimal effect of a given dose may not be achieved. For patients with PSVT and patients with PAF the recommended starting dose is 50 mg every 12 hours. Flecainide acetate doses may be increased in increments of 50 mg bid every four days until efficacy is achieved.

For PAF patients, a substantial increase in efficacy without a substantial increase in discontinuations for adverse experiences may be achieved by increasing the flecainide acetate dose from 50 to 100 mg bid. The maximum recommended dose for patients with paroxysmal supraventricular arrhythmias is 300 mg/day. For sustained VT the recommended starting dose is 100 mg every 12 hours.

This dose may be increased in increments of 50 mg bid every four days until efficacy is achieved. Most patients with sustained VT do not require more than 150 mg every 12 hours (300 mg/day), and the maximum dose recommended is 400 mg/day. In patients with sustained VT, use of higher initial doses and more rapid dosage adjustments have resulted in an increased incidence of proarrhythmic events and CHF, particularly during the first few days of dosing (see WARNINGS ).

Therefore, a loading dose is not recommended. Intravenous lidocaine has been used occasionally with flecainide while awaiting the therapeutic effect of flecainide. No adverse drug interactions were apparent.

However, no formal studies have been performed to demonstrate the usefulness of this regimen. An occasional patient not adequately controlled by (or intolerant to) a dose given at 12-hour intervals may be dosed at eight-hour intervals. Once adequate control of the arrhythmia has been achieved, it may be possible in some patients to reduce the dose as necessary to minimize side effects or effects on conduction.

In such patients, efficacy at the lower dose should be evaluated. Flecainide should be used cautiously in patients with a history of CHF or myocardial dysfunction (see WARNINGS ). Any use of flecainide in children should be directly supervised by a cardiologist skilled in the treatment of arrhythmias in children.

Because of the evolving nature of information in this area, specialized literature should be consulted. Under six months of age, the initial starting dose of flecainide acetate in children is approximately 50 mg/M 2 body surface area daily, divided into two or three equally spaced doses. Over six months of age, the initial starting dose may be increased to 100 mg/M 2 per day.

The maximum recommended dose is 200 mg/M 2 per day. This dose should not be exceeded. In some children on higher doses, despite previously low plasma levels, the level has increased rapidly to far above therapeutic values while taking the same dose.

Small changes in dose may also lead to disproportionate increases in plasma levels. Plasma trough (less than one hour pre-dose) flecainide levels and electrocardiograms should be obtained at presumed steady state (after at least five doses) either after initiation or change in flecainide dose, whether the dose was increased for lack of effectiveness, or increased growth of the patient. For the first year on therapy, whenever the patient is seen for reasons of clinical follow-up, it is suggested that a 12-lead electrocardiogram and plasma trough flecainide level are obtained.

The usual therapeutic level of flecainide in children is 200 to 500 ng/mL. In some cases, levels as high as 800 ng/mL may be required for control. In patients with s…

Contraindications 59 words

CONTRAINDICATIONS Flecainide is contraindicated in patients with preexisting second- or third degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide is also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.

⚠️ Warnings ~3 min read

WARNINGS Mortality Flecainide was included in the National Heart Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days, but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide compared with that seen in a carefully matched placebo-treated group.

This rate was 16/315 (5.1%) for flecainide and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide in this study was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present it is prudent to consider the risks of Class 1C agents (including flecainide), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.

Ventricular Proarrhythmic Effects in Patients with Atrial Fibrillation/Flutter A review of the world literature revealed reports of 568 patients treated with oral flecainide for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF.

FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF) and death. As with other Class 1 agents, patients treated with flecainide for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate. A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive flecainide.

Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication. PROARRHYTHMIC EFFECTS Flecainide, like other antiarrhythmic agents, can cause new or worsened supraventricular or ventricular arrhythmias. Ventricular proarrhythmic effects range from an increase in frequency of PVCs to the development of more severe ventricular tachycardia, e.g., tachycardia that is more sustained or more resistant to conversion to sinus rhythm, with potentially fatal consequences.

In studies of ventricular arrhythmia patients treated with flecainide, three-fourths of proarrhythmic events were new or worsened ventricular tachyarrhythmias, the remainder being increased frequency of PVCs or new supraventricular arrhythmias. In patients treated with flecainide for sustained ventricular tachycardia, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. In studies of 225 patients with supraventricular arrhythmia (108 with paroxysmal supraventricular tachycardia and 117 with paroxysmal atrial fibrillation), there were 9 (4%) proarrhythmic events, 8 of them in patients with paroxysmal atrial fibrillation.

Of the 9, 7 (including the one in a PSVT patient) were exacerbations of supraventricular arrhythmias (longer duration, more rapid rate, harder to reverse) while 2 were ventricular arrhythmias, including one fatal case of VT/VF and one wide complex VT (the patient showed inducible VT, however, after withdrawal of flecainide), both in patients with paroxysmal atrial fibrillation and known coronary artery disease. It is uncertain if flecainide’s risk of proarrhythmia is exaggerated in patients with chronic atrial fibrillation (CAF), high ventricular rate and/or exercise.

Wide complex tachycardia and ventricular fibrillation have been reported in two of 12 CAF patients undergoing maximal exer…

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS In post-myocardial infarction patients with asymptomatic PVCs and nonsustained ventricular tachycardia, flecainide therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group (see WARNINGS ). Adverse effects reported for flecainide, described in detail in the WARNINGS section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF; and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT.

In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, flecainide treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest) (see WARNINGS ).

New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias.

There have also been instances of second- (0.5%) or third-degree (0.4%) AV block. Patients have developed sinus bradycardia, sinus pause, or sinus arrest, about 1.2% altogether (see WARNINGS ). The frequency of most of these serious adverse events probably increases with higher trough plasma levels, especially when these trough levels exceed 1 mcg/mL.

There have been rare reports of isolated elevations of serum alkaline phosphatase and isolated elevations of serum transaminase levels. These elevations have been asymptomatic and no cause and effect relationship with flecainide has been established. In foreign postmarketing surveillance studies, there have been rare reports of hepatic dysfunction including reports of cholestasis and hepatic failure, and extremely rare reports of blood dyscrasias.

Although no cause and effect relationship has been established, it is advisable to discontinue flecainide in patients who develop unexplained jaundice or signs of hepatic dysfunction or blood dyscrasias in order to eliminate flecainide as the possible causative agent. Incidence figures for other adverse effects in patients with ventricular arrhythmias are based on a multicenter efficacy study, utilizing starting doses of 200 mg/day with gradual upward titration to 400 mg/day. Patients were treated for an average of 4.7 months, with some receiving up to 22 months of therapy.

In this trial, 5.4% of patients discontinued due to non-cardiac adverse effects. Table 1 Most Common Non-Cardiac Adverse Effects in Ventricular Arrhythmia Patients Treated with Flecainide in the Multicenter Study Adverse Effect Incidence All 429 Patients at Any Dose Incidence by Dose During Upward Titration 200 mg/Day (N=426) 300 mg/Day (N=293) 400 mg/Day (N=100) Dizziness * 18.9% 11% 10.6% 13% Visual Disturbances † 15.9% 5.4% 12.3% 18% Dyspnea 10.3% 5.2% 7.5% 4% Headache 9.6% 4.5% 6.1% 9% Nausea 8.9% 4.9% 4.8% 6% Fatigue 7.7% 4.5% 4.4% 3% Palpitation 6.1% 3.5% 2.4% 7% Chest Pain 5.4% 3.1% 3.8% 1% Asthenia 4.9% 2.6% 2% 4% Tremor 4.7% 2.4% 3.4% 2% Constipation 4.4% 2.8% 2.1% 1% Edema 3.5% 1.9% 1.4% 2% Abdominal Pain 3.3% 1.9% 2.4% 1% * Dizziness includes reports of dizziness, lightheadedness, faintness, unsteadiness, near syncope, etc. † Visual disturbance includes reports of blurred vision, difficulty in focusing, spots before eyes, etc.

The following additional adverse experiences, possibly related to flecainide therapy and occurring in 1% to less than 3% of patients, have been reported in acute and chronic studies: Body as a Whole - malaise, fever; Cardiovascular - tachycardia, sinus pause…

🆘 Overdosage ~1 min read

OVERDOSAGE No specific antidote has been identified for the treatment of flecainide overdosage. Overdoses ranging up to 8000 mg have been survived, with peak plasma flecainide concentrations as high as 5.3 mcg/mL. Untoward effects in these cases included nausea and vomiting, convulsions, hypotension, bradycardia, syncope, extreme widening of the QRS complex, widening of the QT interval, widening of the PR interval, ventricular tachycardia, AV nodal block, asystole, bundle branch block, cardiac failure and cardiac arrest.

The spectrum of events observed in fatal cases was much the same as that seen in the non-fatal cases. Death has resulted following ingestion of as little as 1000 mg; concomitant overdose of other drugs and/or alcohol in many instances undoubtedly contributed to the fatal outcome. Treatment of overdosage should be supportive and may include the following: removal of unabsorbed drug from the gastrointestinal tract, administration of inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol; mechanically assisted respiration; circulatory assists such as intra-aortic balloon pumping; and transvenous pacing in the event of conduction block.

Because of the long plasma half-life of flecainide (12 to 27 hours in patients receiving usual doses), and the possibility of markedly non-linear elimination kinetics at very high doses, these supportive treatments may need to be continued for extended periods of time. Hemodialysis is not an effective means of removing flecainide from the body. Since flecainide elimination is much slower when urine is very alkaline (pH 8 or higher), theoretically, acidification of urine to promote drug excretion may be beneficial in overdose cases with very alkaline urine.

There is no evidence that acidification from normal urinary pH increases excretion.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Flecainide has local anesthetic activity and belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents; it has electrophysiologic effects characteristic of the IC class of antiarrhythmics. Electrophysiology In man, flecainide produces a dose-related decrease in intracardiac conduction in all parts of the heart with the greatest effect on the His-Purkinje system (H-V conduction). Effects upon atrioventricular (AV) nodal conduction time and intra-atrial conduction times, although present, are less pronounced than those on ventricular conduction velocity.

Significant effects on refractory periods were observed only in the ventricle. Sinus node recovery times (corrected) following pacing and spontaneous cycle lengths are somewhat increased. This latter effect may become significant in patients with sinus node dysfunction (see WARNINGS ).

Flecainide causes a dose-related and plasma-level related decrease in single and multiple PVCs and can suppress recurrence of ventricular tachycardia. In limited studies of patients with a history of ventricular tachycardia, flecainide has been successful 30% to 40% of the time in fully suppressing the inducibility of arrhythmias by programmed electrical stimulation. Based on PVC suppression, it appears that plasma levels of 0.2 to 1 mcg/mL may be needed to obtain the maximal therapeutic effect.

It is more difficult to assess the dose needed to suppress serious arrhythmias, but trough plasma levels in patients successfully treated for recurrent ventricular tachycardia were between 0.2 and 1 mcg/mL. Plasma levels above 0.7 to 1 mcg/mL are associated with a higher rate of cardiac adverse experiences such as conduction defects or bradycardia. The relation of plasma levels to proarrhythmic events is not established, but dose reduction in clinical trials of patients with ventricular tachycardia appears to have led to a reduced frequency and severity of such events.

Hemodynamics Flecainide does not usually alter heart rate, although bradycardia and tachycardia have been reported occasionally. In animals and isolated myocardium, a negative inotropic effect of flecainide has been demonstrated. Decreases in ejection fraction, consistent with a negative inotropic effect, have been observed after single administration of 200 to 250 mg of the drug in man; both increases and decreases in ejection fraction have been encountered during multidose therapy in patients at usual therapeutic doses (see WARNINGS ).

Metabolism in Humans Following oral administration, the absorption of flecainide is nearly complete. Peak plasma levels are attained at about three hours in most individuals (range, 1 to 6 hours). Flecainide does not undergo any consequential presystemic biotransformation (first-pass effect).

Food or antacid do not affect absorption. Milk, however, may inhibit absorption in infants. A reduction in flecainide dosage should be considered when milk is removed from the diet of infants.

The apparent plasma half-life averages about 20 hours and is quite variable (range, 12 to 27 hours) after multiple oral doses in patients with premature ventricular contractions (PVCs). With multiple dosing, plasma levels increase because of its long half-life with steady-state levels approached in 3 to 5 days; once at steady-state, no additional (or unexpected) accumulation of drug in plasma occurs during chronic therapy. Over the usual therapeutic range, data suggest that plasma levels in an individual are approximately proportional to dose, deviating upwards from linearity only slightly (about 10% to 15% per 100 mg on average).

In healthy subjects, about 30% of a single oral dose (range, 10% to 50%) is excreted in urine as unchanged drug. The two major urinary metabolites are meta-0-dealkylated flecainide (active, but about one-fifth as potent) and the meta-0-dealkylated lactam of flecainide (non-active metabolite). These two metabolites (primarily conjugated) account for most of the rem…

📦 How Supplied / Storage and Handling 143 words

HOW SUPPLIED Flecainide Acetate Tablets, USP are available as follows: 50 mg: White, round tablets debossed with “AN” above “641” on one side and plain on other side. Bottles of 100: NDC 53746-641-01 Bottles of 1000: NDC 53746-641-10 100 mg: White, round tablets debossed with “AN” above “642” with a single-line bisect separating them on one side and plain on other side. Bottles of 100: NDC 53746-642-01 Bottles of 1000: NDC 53746-642-10 150 mg: White, oval tablets debossed with “AN”, “643” with a single-line bisect separating them on one side and plain on other side.

Bottles of 100: NDC 53746-643-01 Bottles of 1000: NDC 53746-643-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a tight, light-resistant container. Manufactured by: Amneal Pharmaceuticals Pvt.

Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2017-02

📋 Description 94 words

DESCRIPTION Flecainide acetate is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-, monoacetate. The structural formula is given below.

Molecular formula: C 17 H 20 F 6 N 2 O 3 •C 2 H 4 O 2 Molecular weight: 474.40 Flecainide acetate, USP is a white crystalline substance with a pK a of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide acetate tablets, USP also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose and magnesium stearate.

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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